Webinar: Preparing for IVDR Clinical Performance Studies

In this focused session, we delve into the critical aspects of designing and conducting In Vitro Diagnostic (IVD) performance studies under the stringent requirements of the EU IVDR and ISO 20916. The landscape of IVD performance studies is evolving, with increased regulatory demands for robust, evidence-based demonstrations of safety and performance. This presentation aims to provide attendees with an essential overview, distilled insights, and actionable strategies to navigate these complexities efficiently.

We begin by laying the foundational principles of good study design specific to IVDs, highlighting the critical role of clear objectives, appropriate population selection, and the balance between analytical and clinical performance. The discussion transitions to the pivotal role of ISO 20916 in planning and executing IVD performance studies, emphasizing the standard's contribution to global best practices and regulatory compliance.

The session will uncover challenges and provide practical recommendations for different types of IVDs, including near-patient tests, laboratory-based tests and a special feature on Companion Diagnostic studies, addressing their unique challenges and considerations within the IVDR framework and their interface with clinical trials legislation in pharma.

This session is designed for professionals involved in IVD development, regulatory affairs, clinical research, and quality assurance. Attendees will leave with a clearer understanding of the key requirements, practical challenges, and strategic approaches to successful IVD performance study design and implementation in the era of IVDR and ISO 20916.

Presenters:

• Carlos Galamba, Head of IVD and former Notified Body Clinician and technical expert at BSI.
• Yaiza Benito, Clinical Research Manager and IVD study lead.